NCT02662166

Brief Summary

Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2015

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 25, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

5 years

First QC Date

January 5, 2015

Last Update Submit

June 16, 2020

Conditions

Bladder Cancer

Keywords

bladder cancerMRITUR-BTcystectomychemotherapy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer

    The accuracy of multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer will be evaluated using transurethral resection of bladder tumor and cystectomy specimens

    24 months

Secondary Outcomes (1)

  • Prediction of response to neo-adjuvant chemotherapy and/or BCG treatment evaluated by multiparametric MRI (anatomical MRI, DCE-MRI, DWI)

    24 months

Other Outcomes (1)

  • Estimation of chemosensitivity

    24 months

Study Arms (1)

MRI and biomarkers in bladder cancer

EXPERIMENTAL

Utilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity

Device: MR imaging

Interventions

MR imagingDEVICE

3 T MRI of the urinary bladder

MRI and biomarkers in bladder cancer

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 to 85 years old
  • Suspected BC based on cystoscopical evaluation.
  • Mental status: Patients must be able to understand the meaning of the study
  • Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

You may not qualify if:

  • History of serious cardiovascular, liver or kidney disease
  • Uncontrolled serious infection
  • Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
  • Patient refusing radical cystectomy or chemotherapy or BCG
  • Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Urology, Central Hospital of Pori

Pori, Finland

Location

University of Turku

Turku, 20100, Finland

Location

Related Publications (1)

  • Nikulainen I, Salminen AP, Jambor I, Merisaari H, Tammilehto V, Taimen P, Seikkula H, Bostrom PJ. Visual MRI T-category versus VI-RADS evaluation from multiparametric MRI in the detection of muscle-invasion in patients with suspected bladder cancer: single centre registered clinical trial (MIB-trial). Scand J Urol. 2021 Oct;55(5):354-360. doi: 10.1080/21681805.2021.1971290. Epub 2021 Aug 27.

    PMID: 34448679DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Peter Boström, MD, PhD

    Department of Urology, University of Turku and Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Deah of Department

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 25, 2016

Study Start

July 1, 2014

Primary Completion

July 10, 2019

Study Completion

May 1, 2020

Last Updated

June 17, 2020

Record last verified: 2020-06

Locations

FI(2)